Indications/Uses
Anovulatory infertility.
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Dosage/Direction for Use
Adult: PO 50 mg/day for 5 days, starting at any time if there is no uterine bleeding or on the 5th day of the menstrual cycle. If ovulation does not occur, 100 mg/day for 5 days may be given as early as 30 days after the previous course. Max: 3 courses.
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Administration
May be taken with or without food.
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Contraindications
Abnormal uterine bleeding of unknown origin, ovarian cyst or enlargement not due to polycystic ovarian syndrome, organic intracranial lesion (e.g. pituitary tumour), uncontrolled thyroid or adrenal dysfunction. Active liver disease or history of hepatic impairment. Pregnancy.
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Special Precautions
Patient w/ uterine fibroids, polycystic ovarian syndrome (PCOS). Lactation. Patient Counselling This drug may cause visual disturbances, dizziness, and lightheadedness, if affected, do not drive or operate machinery. Monitoring Parameters Monitor serum oestrogen prior to therapy. Perform pelvic exam and endometrial biopsy before each course and pregnancy test prior to repeat courses. Monitor for ovulation through basal body temp, ultrasound, serum progesterone, oestradiol, and urinary LH. Assess signs and symptoms of ovarian hyperstimulation syndrome (OHSS).
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Adverse Reactions
Significant: Mild to moderate OHSS, visual disturbance (e.g. blurring, scotomata, diplopia, photophobia), endometriosis, ovarian enlargement and cyst formation, risk of multiple or ectopic pregnancy. Rarely, risk of borderline or invasive ovarian cancer.
Nervous: Headache, convulsion, restlessness, insomnia, dizziness, vertigo, lightheadedness, depression, nervous tension, fatigue, insomia.
GI: Nausea, vomiting, constipation, diarrhoea, increased appetite.
Genitourinary: Increased urinary frequency and volume, vag dryness, menorrhagia, uterine haemorrhage, endometriosis.
Endocrine: Vasomotor flushes, heavier menses, hypertriglyceridemia, wt gain.
Hepatic: Jaundice.
Dermatologic: Urticaria, rash, dermatitis, hair loss and dryness.
Others: Breast discomfort.
Potentially Fatal: Severe OHSS manifesting as gross ovarian enlargement, pericardial effusion, severe abdominal pain, ascites, dyspnoea, acute resp distress syndrome, hypotension, tachycardia, thromboembolism, hypovolemic shock, and haemoconcentration. |
Drug Interactions
May enhance adverse effect of ospemifene.
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CIMS Class
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ATC Classification
G03GB02 - clomifene ; Belongs to the class of synthetic agents used as ovulation stimulants.
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